Blumenthal starts antibiotics arms race

Connecticut Sen. Richard Blumenthal LAW ’73 has proposed new steps to combat the dangerous rise of antibiotic resistance.

Blumenthal visited Yale-New Haven Hospital last Monday to promote the bill he recently introduced in the Senate with co-sponsor Sen. Bob Corker of Tennessee, which aims to speed the development of new antibiotics to use against drug-resistant diseases. Jo Handelsman, a Yale professor of molecular, celluar and developmental biology and an antibiotics expert, responded favorably to Blumenthal’s Generating Antibiotic Incentives Now (GAIN) Act, but said further action will be needed to fight antibiotic resistant infections, which kill tens of thousands of Americans each year.

The GAIN Act attempts to make antibiotic research more profitable by extending the duration of patents of certain antibiotics and giving those drugs prioritized, or “fast-track,” FDA evaluation. These changes will incentivize pharmaceutical companies to develop more antibiotics than they are currently doing, according to a press release from Blumenthal’s office.

“The GAIN Act will certainly help the problem,” Handelsman said. “Today, it’s an extremely bleak situation. Only a small percentage of the pharmaceutical industry is actively researching new antibiotics.”

The problem has been building over the last few decades, Handelsman explained. In the 1960s, a flood of research led to numerous antibiotics on the market, but then many groups, including doctors, pharmaceutical companies and patients, became complacent about their use. Pharmaceutical companies eventually began focusing on drugs that treat chronic illnesses, which are more profitable to produce, Handelsman said.

Brad Spellberg, professor of medicine at UCLA, said the bill is “a good first step,” but argued that more needs to be done.

“The incentives could be much stronger, and the fast-track evaluation isn’t going to work at all. Important antibiotics already get fast-tracked,” Spellberg said.

He added that the FDA’s regulatory protocols were slowing the introduction of new antibiotics by making “it extremely difficult to conduct trials.” Spellberg is the co-chair of the Antimicrobial Availability Task Force at the Infectious Disease Society of America.

David Livermore, director of the U.K.-based Antibiotic Resistance Monitoring & Reference Laboratory, also said the regulatory process was too onerous. He added that regulations were posing an additional burden at a time when, for a variety of reasons, not many new antibiotics were being produced.

Handelsman also cautioned that, even with appropriate incentives, pharmaceutical companies might not have the manpower or the expertise to begin immediately developing new antibiotics.

“Once they stop researching antibiotics, it can be difficult to get started again,” she said.

The costs of ignoring the problem could be catastrophic, all three scientists concurred. According to a statement from Blumenthal’s office, antibiotic-resistant Staph infections are responsible for over 17,000 deaths in the United States each year. A large number of these infections occur in hospitals, where patients with weakened immune systems are exposed to many antibiotic-resistant diseases, Handelsman said.

“Hospitals are now dangerous in ways that they haven’t been for 40 years,” Handelsman said. “They are now one of the most common places to get an infection.”

Yale and other academic institutions will be needed to take the lead in antibiotics research, she said, adding that new breakthroughs by academic researchers could spur pharmaceutical companies into action.

Livermore agreed with importance of further academic research, but he also emphasized the necessity of ensuring that pharmaceutical companies mass-produce new antibiotics.

Handelsman’s own lab is currently researching how antibiotic-resistant genes spread in bacterial populations.